The ICH GCP Guidelines define Essential Documents as those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of data produced. These documents serve to demonstrate compliance with standards of Good Clinical Practice and with all applicable regulatory requirements. Filing essential documents in a timely manner can greatly assist in the successful management of a clinical trial.
The Regulatory files are often the first series of documents reviewed during audits and inspections. Not all the essential documents are available at the start of the study. Documents can be grouped into those that are generated before study initiation, those that are generated during trial conduct and those that are generated after study completion.
At ACR, we can provide a multitude of services ranging from consulting on best practices to maintain these files to handling the documents for you to ensure proper completion, organization, and structure.